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OpenTrials
Completed

NCT Number: NCT06897878

Optimal Number of Pleural Biopsies During Pleuroscopy

A single-center, non-randomized, prospective observational, pilot study designed to determine what is the optimal number of pleural biopsies to take during pleuroscopy.

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Key information

Conditions

Pleural Diseases Pleural Effusion Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mount Sinai Hospital

New York, 10028, United States

About this study

After enrollment, participants will undergo pleural biopsies via pleuroscopy. Specimens will be divided into three aliquots (1-3, 4-6, 7-10), which will be sent to pathology. A designated pathologist will evaluate the specimens in each aliquot to determine the number of biopsies required to reach a diagnosis and to obtain sufficient material for biomarker testing (when needed), and determine whether analysis of further aliquots is needed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consecutive patients who require pleuroscopies will be enrolled to the study.
  • Age ≥ 18

Exclusion criteria

  • Inability to provide informed consent

Treatment and study plan

Primary outcomes

  1. Number of pleural biopsies to reach a diagnosis

    Time frame: At week 2 after pleuroscopy

    The number of pleural biopsies needed to reach a diagnosis.

Secondary outcomes

  1. Number of pleural biopsies required for comprehensive biomarker testing.

    Time frame: At week 4 after pleuroscopy

    The number of biopsies required to obtain sufficient material for comprehensive biomarker testing.

  2. Number of complications

    Time frame: At week 4 after pleuroscopy

    Number of complications related to the biopsy.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Acronym: OPTIBIOP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2025
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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